(1) Hypertension, or high blood pressure, generally means a systolic blood pressure of greater than 140 millimeters of mercury (mm Hg) or a diastolic blood pressure of greater than 90 mm Hg. Normotension, or normal blood pressure, is a systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. Sodium is specified here as the chemical entity or electrolyte “sodium” and is distinguished from sodium chloride, or salt, which is 39 percent sodium by weight.

(2) The scientific evidence establishes that diets high in sodium are associated with a high prevalence of hypertension or high blood pressure and with increases in blood pressure with age, and that diets low in sodium are associated with a low prevalence of hypertension or high blood pressure and with a low or no increase of blood pressure with age.

(b)Significance of sodium in relation to high blood pressure.

(1) High blood pressure is a public health concern primarily because it is a major risk factor for mortality from coronary heart disease and stroke. Early management of high blood pressure is a major public health goal that can assist in reducing mortality associated with coronary heart disease and stroke. There is a continuum of mortality risk that increases as blood pressures rise. Individuals with high blood pressure are at greatest risk, and individuals with moderately high, high normal, and normal blood pressure are at steadily decreasing risk. The scientific evidence indicates that reducing sodium intake lowers blood pressure and associated risks in many but not all hypertensive individuals. There is also evidence that reducing sodium intake lowers blood pressure and associated risks in many but not all normotensive individuals as well.

(2) The populations at greatest risk for high blood pressure, and those most likely to benefit from sodium reduction, include those with family histories of high blood pressure, the elderly, males because they develop hypertension earlier in life than females, and black males and females. Although some population groups are at greater risk than others, high blood-pressure is a disease of public health concern for all population groups. Sodium intake, alcohol consumption, and obesity are identified risk factors for high blood pressure.

(3) Sodium intakes exceed recommended levels in almost every group in the United States. One of the major public health recommendations relative to high blood pressure is to decrease consumption of salt. On a population-wide basis, reducing the average sodium intake would have a small but significant effect on reducing the average blood pressure, and, consequently, reducing mortality from coronary heart disease and stroke.

(4) Sodium is an essential nutrient, and experts have recommended a safe minimum level of 500 milligrams (mg) sodium per day and an upper level of 2,400 mg sodium per day, the FDA Daily Value for sodium.

(i)Nature of the claim. A health claim associating diets low in sodium with reduced risk of high blood pressure may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in sodium “may” or “might” reduce the risk of high blood pressure;

(B) In specifying the disease, the claim uses the term “high blood pressure”;

(D) The claim does not attribute any degree of reduction in risk of high blood pressure to diets low in sodium; and

(E) The claim indicates that development of high blood pressure depends on many factors.

(ii)Nature of the food. The foodshall meet all of the nutrient content requirements of § 101.61 for a “low sodium” food.

(d)Optional information.

(1) The claim may identify one or more of the following risk factors for development of high blood pressure in addition to dietary sodium consumption: Family history of high blood pressure, growing older, alcohol consumption, and excess weight.

(2) The claim may include information from paragraphs (a) and (b) of this section, which summarizes the relationship between dietary sodium and high blood pressure and the significance of the relationship.

(3) The claim may include information on the number of people in the United States who have high blood pressure. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or “Nutrition and Your Health: Dietary Guidelines for Americans,” U.S. Department of Health and Human Services (DHHS) and U.S. Department of Argiculture (USDA), Government Printing Office.

(4) The claim may indicate that it is consistent with “Nutrition and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA, Government Printing Office.

(5) In specifying the nutrient, the claim may include the term “salt” in addition to the term “sodium.”

(6) In specifying the disease, the claim may include the term “hypertension” in addition to the term “high blood pressure.”

(7) The claim may state that individuals with high blood pressure should consult their physicians for medical advice and treatment. If the claim defines high or normal blood pressure, then the health claim must state that individuals with high blood pressure should consult their physicians for medical advice and treatment.

(e)Model health claims. The following are model health claims that may be used in food labeling to describe the relationship between dietary sodium and high blood pressure:

(1) Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.

(2) Development of hypertension or high blood pressure depends on many factors. [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure.

Submit either electronic or written comments on the proposed rule by February 16, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 18, 2015.

21 CFR Part 101

Summary

The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the “gluten-free” labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as “gluten-free.” There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a “gluten-free” claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the “gluten-free” claim and made available to us for inspection and copying. The records would need to provide adequate assurance that the food is “gluten-free” in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the “gluten-free” claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the “gluten-free” claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are “gluten-free” in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

2015-11-12; vol. 80 # 218 - Thursday, November 12, 2015

80 FR 69905 - Use of the Term “Natural” in the Labeling of Human Food Products; Request for Information and Comments

The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. We are taking this action in part because we received three citizen petitions asking that we define the term “natural” for use in food labeling and one citizen petition asking that we prohibit the term “natural” on food labels. We also note that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as “natural.” We are working with the United States Department of Agriculture (USDA) Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term “natural” in meat, poultry, and egg products, and are considering areas for coordination between FDA and USDA. We invite public comment on the term “natural” in the context of food labeling and on specific questions contained in this document.

2015-10-20; vol. 80 # 202 - Tuesday, October 20, 2015

80 FR 63477 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period

Submit either electronic or written comments on the supplemental proposed rule and related documents by October 23, 2015.

21 CFR Part 101

Summary

The Food and Drug Administration (FDA or we) is announcing the reopening of the comment period for certain documents associated with the proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices. We also are reopening the comment period for a supplemental proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are taking this action due to technical difficulties at the Federal eRulemaking Portal.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 2, 2015.

21 CFR Parts 11 and 101

Summary

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11); Draft Guidance for Industry.” The draft guidance, when finalized, will help certain restaurants and similar retail food establishments comply with the menu labeling requirements, including the requirements to provide calorie and other nutrition information for standard menu items, including food on display and self-service food.

We are extending the comment period that was scheduled to close on September 25, 2015, until October 13, 2015.

21 CFR Part 101

Summary

The Food and Drug Administration (FDA or we) is announcing the availability of certain documents to update the administrative docket of the proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 28, 2015.

21 CFR Part 101

Summary

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled “FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.” The draft guidance, when finalized, will explain to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.

Submit either electronic or written comments on the supplemental notice of proposed rulemaking by October 13, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by August 26, 2015, (see the “Paperwork Reduction Act of 1995” section of this document).

21 CFR Part 101

Summary

The Food and Drug Administration (FDA or we) is revising certain provisions of the proposed rule, issued in March 2014, that would amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices (“the NFL/SFL proposed rule”). We are proposing text for the footnotes to be used on the Nutrition Facts label. We are taking this action after completing our consumer research in which we tested various footnote text options for the label. We are also proposing to establish a Daily Reference Value (DRV) of 10 percent of total energy intake from added sugars, proposing to require the declaration of the percent Daily Value (DV) for added sugars on the label, and are providing additional rationale for the declaration of added sugars on the label. We are taking these actions based, in part, on the science underlying a new report released by the 2015 Dietary Guidelines Advisory Committee.

80 FR 44302 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents

The comment period for the proposed rule published March 3, 2014 (79 FR 11879), is reopened for the limited purpose described in this document. Submit either electronic or written comments by September 25, 2015.

21 CFR Part 101

Summary

The Food and Drug Administration (FDA or we) is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.

Effective date: This final rule is effective December 1, 2015. Compliance date: Covered establishments must comply with the rule published December 1, 2014 (79 FR 71156) by December 1, 2016.

21 CFR Parts 11 and 101

Summary

The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for further clarification of the rule's requirements.